Transgene terminates oncolytic IO combo trial in advanced liver cancer
pharmafile | August 8, 2019 | News story | Research and Development | Cancer, Transgene, clinical trials, liver cancer, pharma
Biotech firm Transgene has announced its decision to terminate a study investigating the efficacy of its oncolytic immunotherapy product Pexa-Vec in the treatment of advanced liver cancer in patients who have not received prior systemic treatment following a planned interim futility analysis from the independent Data Monitoring Committee (IDMC).
The analysis revealed that the therapy was unlikely to meet its primary endpoint by the end of the study – the statistically significant improvement of overall survival when followed by Bayer’s Nexavar (sorafenib).
The company said it is in the process of analysing trial data procured by its partner, South Korean biotech SillaJen, which conducted the study, singling out findings from an ongoing Phase 2 evaluating Pexa-Vec combined with Bristol-Myers Squibb’s Opdivo in the same indication as the cancelled trial. No safety issues were reported in
Despite the disappointing outcome, Transgene said that it remains “convinced of the great potential of oncolytic viruses”, due to their ability to infect and selectively replicate within cancerous tumours to trigger destruction of its cells and signal a strong retaliatory immune response from the body.
Dr Philippe Archinard, Chairman and CEO of Transgene, commented: “We are obviously disappointed with the outcome of the PHOCUS study; however we remain convinced in the potential of our oncolytic virus pipeline. Our recent collaborative agreement with AstraZeneca highlights the industry interest in the multi-armed OVs that we can generate using our unique Invir.IO platform. We also expect to announce the first clinical data with TG6002 in patients with colorectal cancer later this year. In addition, we expect to announce important clinical results from our most advanced therapeutic vaccines; TG4010 in lung cancer and TG4001 in HPV-Positive head and neck cancer. With funding through to 2022, a clear strategy and novel technology platforms such as Invir.IO and myvac, Transgene is well placed to demonstrate the potential of its novel medicines designed to improve the treatment of solid tumours.”
Matt Fellows
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